BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM

    MDR report key: 436996 · Received January 9, 2003

    Report

    Report Number
    1725056-2002-00001
    Event Type
    Injury
    Date Received
    January 9, 2003
    Date of Event
    December 11, 2002
    Report Date
    January 9, 2003
    Manufacturer
    MEDIVANCE, INC.
    Product Code
    DWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A 9 1/2 HOUR, ON-PUMP, CABG/RE-DO VALVE REPLACEMENT SURGERY. AT THE CONCLUSION OF SURGERY AND THE REMOVAL OF THE DEVICE, A REDDENED AREA WAS NOTED ON THE MID-LEFT BACK. WITHIN 12 HOURS THE AREA BECAME AN OPEN BLISTER, APPROXIMATELY 3 IN X 3 IN. A SMALL CLOSED BLISTER WAS ALSO NOTED ON THE LOWER BACK. THE SKIN INJURY ON THE MID BACK REQUIRED TREATMENT WITH SILVER-IMPREGNANTED DRESSINGS AND EXTENDED THE PATIENT'S HOSPITAL STAY. NO TREATMENT WAS REQUIRED FOR THE BLISTER ON THE LOWER BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM THERMAL REGULATING SYSTEM DWC MEDIVANCE, INC. 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization